The treatment of respiratory ailments often includes the delivery of medications by the use of a nebulizer. Typically a nebulizer works by using an air compressor and a nebulizer cup in order to turn medication into a vapor mist or fog for the patient to inhale. A variety of nebulizer constructions are known to exist and the vapor mist or fog of medication may be inhaled passively (from the surrounding atmosphere) or inhaled actively by the use of an inhaler. Each inhalation approach includes certain drawbacks which offer opportunities for design improvements.
In the case of passive inhaling, the nebulizing process dilutes the medication as it diffuses from the nebulizer machine into the surrounding atmosphere. As a result of this dilution, a more concentrated dose of medicine is required in order to achieve the desired treatment. This process, as described, may be “acceptable” for certain medicines and certain treatments, at least from a cost perspective when the medicine is a relatively low cost item. However, when the nebulizing procedure is used for cell therapy, the modified cells are too precious to waste. Even if we discount the loss of modified cells to the surrounding atmosphere, there are further losses associated with the act of inhaling, whether active or passive inhaling. Active inhaling causes some of the nebulized cells to be absorbed by the mouth and throat tissues before reaching the site needing or targeted for the therapy.
In addition to the fact that the modified cells are too precious to waste, the therapy is more effective when the modified cells are delivered directly to the localized area, including the patient site which will primarily benefit from the treatment. The typical delivery process for respiratory treatment, consistent with the prior art, consists of atomizing the modified cells and then allowing normal respiration to distribute the cells somewhat uniformly to the entire lung.
As noted, modified cells are too precious to waste. Further, the therapy is more effective when the modified cells are directed in a more focused or targeted manner directly to the area or patient site which will benefit from the treatment. When the delivery of nebulized modified cells, via normal respiration, extends to the entire lung, some other areas or portions of the lung receive the modified cells which are not part of the area or location targeted for treatment. Since these “other” areas of the lung are not intended for treatment and thus would understandably not benefit from receiving the modified cells, a portion of the modified cells which are delivered to the lung are “wasted”. The disclosed embodiment addresses this prior art issue by providing a nebulizing catheter which includes the use of a bronchoscope for catheter delivery and for positioning the dispensing tip of the catheter at or near the selected treatment site within a lung of the patient or subject.
In the context of the present disclosure, other prior art methods of fog-generation for respiratory treatment create droplets larger than those formed by nebulizing. The result of having larger droplets means that uptake by the smallest bronchioles and alveoli will be inhibited and the intended treatment less effective. In part, this is why nebulizing is a preferred approach for cell therapy, using modified cells. However, the prior art forms of nebulizing and the prior art methods of treatment are improved upon by the disclosed embodiment and the associated method.
Nebulizing results in the creation of smaller-sized droplets, and thus the reference to “fog”, as these smaller-sized droplets are of “mist” size and carried by an air flow. These smaller droplets are able to reach farther into smaller passageways of the lungs before uptake. Because the nebulized droplets are smaller, they exhibit better uptake via cell-wall transfer. A result of this is that small dosages of the modified-cell solution (referred to herein as a “liquid mixture”) can be effective when applied directly to the treatment area or site.